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Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy

U

University Hospital Freiburg

Status and phase

Completed
Phase 4

Conditions

Pain, Postoperative

Treatments

Procedure: intrathecal opioids and thoracic paravertebral analgesia
Procedure: thoracic epidural analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT00493909
TL-2007-06

Details and patient eligibility

About

The purpose of this study is to compare whether epidural analgesia would provide equal analgesia than combining intrathecal opioids with thoracic paravertebral local anesthetics.

Full description

Thoracotomy is an invasive surgical procedure, which is mainly performed in patients with pre-existing lung disease such as lung cancer or chronic obstructive pulmonary disease. Pain after thoracotomy is considered the most intense acute postoperative pain, adversely affecting the ability to cough, deep breathing, and lung function, resulting in respiratory complications and delayed recovery. The adverse effects can be further aggravated by occurrence of chronic post-thoracotomy pain.

Thoracic epidural analgesia is often recommended as the gold standard for the relief of acute post-thoracotomy pain. Thoracic paravertebral blockade or intrathecal opioid analgesia has also been shown to be efficacious for pain relief. Since there is no ideal single regional technique for pain relief after thoracotomy an alternative method maybe the combination of low-dose intrathecal morphine and sufentanil plus continuous thoracic paravertebral analgesia with local anesthetics.

We therefore hypothesized that combining intrathecal sufentanil and morphine with thoracic paravertebral applicated ropivacaine would provide equal analgesia compared to thoracic epidural analgesia with ropivacaine and sufentanil. We further speculate that this new regimen would have a lower incidence of typical side effects due to TEA, such as block failure, hypotension or urinary retention.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Sex: male/female
  • Age: 18 - 75 years
  • Informed consent of the patient
  • Elective thoracotomy
  • Two chest drains

Exclusion criteria

  • Contraindications against the use of regional techniques: known allergy to local anesthetics
  • Infection around the puncture site
  • Coagulation disorders
  • Drug abuse
  • Emergency surgery
  • Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

1
Active Comparator group
Description:
thoracic epidural analgesia
Treatment:
Procedure: thoracic epidural analgesia
Procedure: intrathecal opioids and thoracic paravertebral analgesia
2
Active Comparator group
Description:
intrathecal opioids and thoracic paravertebral analgesia
Treatment:
Procedure: intrathecal opioids and thoracic paravertebral analgesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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